The following data is part of a premarket notification filed by Medacta Inernational Sa with the FDA for Mectalif Transforaminal Tipeek.
Device ID | K200551 |
510k Number | K200551 |
Device Name: | MectaLIF Transforaminal TiPEEK |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Medacta Inernational SA Strada Regina Castel San Pietro, CH Ch-6874 |
Contact | Stefano Baj |
Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-03-03 |
Decision Date | 2021-02-12 |